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Nurs Midwifery Stud. 2015 June; 4(2): e25800.

DOI: http://dx.doi.org/10.17795/nmsjournal25800
Published online 2015 June 27. Research Article

Effect of Music Therapy on Patients’ Anxiety and Hemodynamic


Parameters During Coronary Angioplasty: A Randomized Controlled
Trial
1,* 2 3
Masoumeh Forooghy ; Elaheh Mottahedian Tabrizi ; Ebrahim Hajizadeh ; Bahram
4
Pishgoo
1Department of Critical Care Nursing, Nursing Faculty, Baqiyatallah University of Medical Sciences, Tehran, IR Iran
2Behavioral Sciences Research Center (BSRC), Baqiyatallah University of Medical Sciences, Tehran, IR Iran
3Department of Bio-Statistics, School of Medical Sciences, Tarbiat Modares University, Tehran, IR Iran
4Department of Cardiology, School of Medical Sciences, Baqiyatallah University of Medical Sciences, Tehran, IR Iran

*Corresponding author: Masoumeh Forooghy, Department of Critical Care Nursing, Nursing Faculty, Baqiyatallah University of Medical Sciences, Tehran, IR Iran. Tel: +98-2144810891;
Fax: +98-2126127237, E-mail: forooghy619@yahoo.com

Received: December 3, 2014; Revised: April 26, 2015; Accepted: April 26, 2015

Background: A cardiac catheterization laboratory can be a frightening environment and music can be a supportive source of
environmental sound that stimulates and maintains relaxation. However, the results of studies are conflicting in this regard.
Objectives: The aim of this study was to investigate the effect of music therapy on patients’ anxiety and hemodynamic parameters during
percutaneous transluminal coronary angioplasty.
Patients and Methods: This was a randomized controlled trial, conducted in the Catheterization Laboratory Unit of Baqiyatallah
Hospital, in Tehran, Iran. A sample of 64 patients, who were planned to undergo coronary angioplasty, was recruited. Patients were
randomly allocated to either the control or the experimental groups. In the experimental group, patients received a 20 to 40-minute
music therapy intervention, consisting of light instrumental music albums by Johann Sebastian Bach and Mariko Makino. Patients in the
control group received the routine care of the study setting, which consisted of no music therapy intervention. Study data were collected
by a demographic questionnaire, the Spielberger’s State Anxiety Inventory, and a data sheet for documenting hemodynamic parameters.
Chi-square, independent-samples t tests, paired-samples t-test and repeated measures analysis of variance were used to analyze the data.
Results: Before the intervention, the study groups did not differ significantly in terms of anxiety level and hemodynamic parameters.
Moreover, the differences between the two groups, regarding hemodynamic parameters, were not significant after the intervention (P >
0.05). However, the level of post-intervention anxiety in the experimental group was significantly lower than the control group (32.06 ±
8.57 and 38.97 ± 12.77, respectively; P = 0.014). Compared with the baseline readings, the level of anxiety in the control group did not change
significantly after the study (41.91 ± 9.88 vs. 38.97 ± 12.77; P = 0.101); however, in the experimental group, the level of post-intervention anxiety
was significantly lower than the pretest readings (32.06 ± 8.57 vs. 41.16 ± 10.6; P = 0.001).
Conclusions: Music therapy is a safe, simple, inexpensive, and non-invasive nursing intervention, which can significantly alleviate
patients’ anxiety during coronary angioplasty.

Keywords: Music Therapy; Coronary Angioplasty; Anxiety; Hemodynamics

1. Background
Percutaneous transluminal coronary angioplasty Anxiety is an emotional state, which is associated with
(PTCA) is one of the most common invasive procedures tension, anger, apprehension, fear, increased serum lev-
performed in patients with coronary artery diseases els of epinephrine and norepinephrine, heightened au-
(CAD). This procedure involves advancing a balloon- tonomic activity, and activated stress responses, which
tipped catheter through a coronary artery to dilate the collectively expand the workload of the cardiovascular
stenotic area of the vessel lumen and improve the coro- system (7). The major causes of anxiety in patients who
nary artery blood flow (1). Patients who are expected to undergo PTCA are the noises of angioplasty equipment,
undergo cardiac catheterization experience consider- healthcare professionals’ talks, pain, unfamiliar environ-
able anxiety (2-4). Astin et al. have reported that more ment of the catheterization laboratory, fear of the results
than 36% of patients who undergone PTCA experienced and the complications of the procedure, previous experi-
sever anxiety (5). Another study has reported that the ences of PTCA, probability of requiring surgery and hav-
prevalence of acute and chronic anxiety in these patients ing uncertainty over future (8).
is 70 - 80% and 20 - 25%, respectively (6). Feeling severe anxiety during a critical procedure, such

Copyright © 2015, Kashan University of Medical Sciences. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non-
Commercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/) which permits copy and redistribute the material just in noncommercial
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Forooghy M et al.

as PTCA, can increase the risk for developing mental and 2. Objectives
physical problems (9). Anxiety increases heart rate (HR)
The aim of this study was to investigate the effect of
and blood pressure (BP) (10, 11), expands cardiac output,
music therapy on anxiety and hemodynamic parameters
heightens cardiac workload, and increases myocardial
among patients receiving PTCA.
oxygen demand and the length of hospital stay (12). Giv-

3. Patients and Methods


en the profound effects of anxiety on different systems of
the body, anxiety management is one of the major nurs-
ing priorities (4, 13).
There are multiple pharmacological strategies for man- 3.1. Study Design and Participants
aging PTCA-associated anxiety (9). However, anxiolytic This was a non-blind, two-group parallel, randomized,
medications are usually associated with different side ef- controlled trial that was conducted on patients undergo-
fects, as well as the likelihood of developing drug depen- ing PTCA in the catheterization lab units of Baqiyatallah
dence (14). Hospital, Tehran, Iran. The study was conducted from
Consequently, there is currently a growing desire for January to April 2014.
using non-pharmacological anxiety management strate- The sample size was calculated using the results of a pre-
gies. For instance, Molavi Vardanjani et al. made use of re- vious study (10). Considering a power of 80%, the type I er-
flexology (15), while Adib-Hajbaghery et al. used a multi- ror probability of 95%, the Pocock’s sample size formula,
dimensional package (16) to alleviate the cardiac patients’ and a medium effect size (0.5), a total of 32 patients were
anxiety. One of the most common non-pharmacological estimated to be necessary in each group. Therefore, 64
anxiety management strategies is music therapy (17). patients were consecutively recruited and randomly allo-
Music therapy is a safe, simple, inexpensive, and non-in- cated to either the experimental or the control groups (32
vasive nursing intervention, which can be used as a com- patients in each group). The first and the second patients
plementary therapy for anxiety management (18, 19). It were randomly allocated to respectively the control and
can promote patients’ comfort through enhancing stress the experimental groups and then, other patients were
threshold, regulating the internal processes of the body, allocated alternately.
and boosting immunity (20, 21). Almerud and Petersson The inclusion criteria were: patient’s desire for partici-
have noted that music stimulates the central nervous pating in the study; undergoing PTCA for the first time;
system to produce endorphins. Endorphins are endog- being able to understand and speak Persian; having an
enous morphine-like substances, which can decrease BP, age of 45 - 82 years; having no hearing impairment; hav-
HR, and respiratory rate and promote relaxation through ing no drug or alcohol addiction; having no previous
alleviating fear and anxiety (22). In a review study, Vander- history of complicated gross surgeries or undergoing
boom has noted that non-pharmacological anxiety man- a PTCA; receiving no anxiolytic medication during the
agement strategies, such as music therapy, can decrease past 6 months; having no history of severe psychologi-
patients’ HR and BP and eliminate the need for general cal disorder during the past 6 months; and needing no
anesthesia during invasive procedures (23). On the other emergency cardiac catheterization. Patients who chose
hand, music can alleviate patients’ pain and anxiety by to withdraw from the study, needed emergency inter-
distracting their attention from anxiety-producing fac- vention for treating cardiac dysrhythmias, or had to
tors (24). Probably, music exerts its anxiolytic effects undergo emergency open-heart surgery were excluded
through interacting with perceptive, cognitive, and affec- from the study.
tive processes and also, through preventing patients from
hearing the sounds that fill operating rooms and cath-
3.2. The instruments
eterization laboratories. Moreover, music-induced posi-
tive feelings and mood improvements can help manage Data were collected using a demographic question-
clinical conditions, such as pain and anxiety (25). Nilsson naire, a data sheet for documenting hemodynamic
(26) and Sendelbach et al. (27) have studied the effect of parameters and the Spielberger’s State Anxiety Inven-
music intervention on stress response in patients under- tory (SSAI). A panel of experts affiliated to the Faculty of
going cardiac surgery and reported that the intervention Nursing, Baqiyatallah University of Medical Sciences,
was not significantly effective. Due to the inconsistencies Tehran, Iran, confirmed the content validity of the first
in the results of previous studies, more investigations are two parts of the instrument. The demographic question-
yet needed to fully understand the effect of music inter- naire consisted of questions on patients’ demographic
vention on patients undergoing cardiac procedures. On characteristics, including the subjects’ age, gender, level
the other hand, many of the researchers applied their of education, and marital status. The SSAI consists of 20
intervention before the cardiac procedures (15, 16) and questions which measure anxiety state on a four-point
few studies are available on the effect of music therapy scale, ranging from Never (scored 1) to Always (scored 4).
implemented during the procedure, on PTCA-associated Several questions have been worded negatively, which
anxiety. Therefore, the present study was conducted to should be scored reversely. The possible total score of the
address this knowledge gap. SSAI would be 20‒80. Higher scores stand for more severe

2 Nurs Midwifery Stud. 2015;4(2):e25800


Forooghy M et al.

state anxiety. The Persian version of the SSAI was vali- 3.5. Data Analysis
dated by Yeganehkhah et al. and its reliability has been
We used the SPSS, v. 13 (SPSS Inc., Chicago, IL, USA) for
confirmed through internal consistency method, with a
data analysis. Study data were described using frequency
Coronbach’s alpha of 0.852 (28).
tables and the measures of central tendency. The Chi-

3.3. Intervention
square and the independent-samples t tests were used
for between-group comparisons. Moreover, the paired-
On a daily basis, the first author referred to the cardiac samples t-test was used for within-group comparisons.
care units of the study setting and recruited the eligible We also employed the within-subjects repeated measures
patients to the study. Data collection was performed at analysis of variance (RMANOVA) to compare the differ-
patients’ bedside. All patients were asked to complete ences of hemodynamic variables across the five measure-
the demographic questionnaire and the SSAI. Thereafter, ment time-points. Pairwise comparison was performed
when patients were admitted to the catheterization lab, by using the post-hoc Bonferroni’s test. The P values
we measured their baseline vital signs and allocated them which were less than 0.05 were considered as significant.
alternately, to one of the study groups. Hemodynamic pa-
rameters of all patients, including systolic and diastolic BP 4. Results
(SBP and DBP), HR and percutaneous oxygen saturation
Four patients from the control group (one patient be-
(SaO2) were monitored using the catheterization device
cause of developing bradycardia and three patients be-
(Siemens, Germany) and the X110 Cardioset monitoring
cause of having an unsuccessful PTCA) and four patients
device (Iran Electronics Industries, Tehran, Iran) at five
from the experimental group (three patients because of
time-points. The X110 Cardioset monitoring device was
rejecting the music intervention after 5 minutes and one
calibrated by the manufacturer. The measurement time-
patient because of accidental removal of the headphone)
points were 10 minutes before PTCA (T1), immediately after
were excluded from the study. Accordingly, we recruited
starting it (T2), 10 and 20 minutes after starting it (T3 and
eight more patients in the follow-up step (Figure 1).
T4), and 30 minutes after its completion (T5). The anxiety
posttest was also performed, 30 minutes after PTCA. Given
the fact that patient’s chest was not visible during the pro- Table 1. Demographic Characteristics of the Study Groups a
cedure, respiratory rate was measured only twice (T1 and
Variable Group P Value
T5). Patients’ hemodynamic parameters were monitored
while they were in the supine position. Control Experimental
The music intervention started 6 minutes after local an- Education level 0.205 b
esthesia of the groin site with lidocaine (i.e. immediately
before inserting the arterial sheath and catheter). All Illiterate 3 (9.4) 8 (25)
patients received the same dose of lidocaine. Music was Primary education 4 (12.5) 5 (15.6)
played using a digital MP3 player and a headphone. The
Secondary education 9 (28.1) 11 (34.4)
music consisted of light instrumental music albums by
Johann Sebastian Bach and Mariko Makino. This album Diploma 9 (28.1) 3 (9.4)
has been shown to affect the cardiovascular system (29).
Academic degree 7 (21.9) 5 (15.6)
Music therapy sessions lasted for 20 - 40 minutes, depend-
ing on the length of PTCA. We used headphones to help Marital status 0.356 c
patients concentrate on the played music and to prevent
Single 0 1 (3.1)
the played music from disturbing catheterization labora-
tory personnel. Headphones were disposable and were Married 32 (100) 30 (93.8)
disinfected before use. The patients in the control group Widow 0 1 (3.1)
were treated similar to the intervention group, except
that they did not receive the music intervention. All pa- Divorced 0 0
tients also received the routine care of the study setting. Gender 0.434 b

3.4. Ethical Considerations


Male 19 (59.4) 22 (69)

Female 13 (46.6) 10 (31)


The Ethics Committee of Baqiyatallah University of
Medical Sciences, Tehran, Iran, approved the study (the Age, y 56.78 ± 8.47 60 ± 9.53 0.54 d
approval code was S/340/3/6770). Patients were informed Duration of the pro- 35.64 ± 11.81 31.41 ± 11.16 0.148 d
of the study aim. They were free to choose whether to par- cedure, min
ticipate or withdraw from the study at any time. More- a Data are presented as No. (%) or Mean ± SD.
over, we ensured them that withdrawing from the study b Chi-square Test.
never affects their course of treatment. Written informed c Exact Fisher’s test.
consent was obtained from all patients. d Independent-samples t-test.

Nurs Midwifery Stud. 2015;4(2):e25800 3


Forooghy M et al.

Assessed for eligibility (n=110)

Excluded (n= 54)

Not meeting inclusion criteria (n=40)

Refused to participate (n=6)


Randomized (n= 64)

ALLOCATION

Allocated to Control (n=32) Allocated to intervention (n=32)

FOLLOW -UP

Lost to follow-up (n =4) (one patient because of


developing bradycardia and three patients Lost to follow-up (n =4) (three patients
because of having an unsuccessful PTCA) because of rejecting the music therapy
intervention after five minute and one
Inclusion (n=4) patient because of accidental removal of
the headphone)
Discontinued intervention (To achieve the Inclusion (n=4)
desired number) Discontinued intervention (To achieve the
desired number)

ANALYSIS

Analyzed (n=32) Analyzed (n=32)


Excluded from analysis (give reasons) (n=0) Excluded from analysis (give reasons) (n=0)

*Screening and collect baseline information

Figure 1. CONSORT Flow Diagram Participant Recruitment Intervention and Control

Participants ranged in age from 45 to 81 years, with a Moreover, the study groups did not differ significantly
mean age of 58.39 ± 9.09 years. The mean age of partici- in terms of hemodynamic parameters at different mea-
pants in the control and the experimental groups were surement time-points (P > 0.05; Table 2). However, after
56.78 ± 8.47 and 60.00 ± 9.53, respectively. Totally, 41 male the intervention, the level of anxiety in the experimen-
(64.06%) and 23 female (35.94%) patients participated in tal group was significantly lower than the control group
the study. No significant differences were found between (32.06 ± 8.57 vs. 38.97 ± 12.77, respectively; P = 0.014; Table
the two groups in terms of demographic variables, such 3). Moreover, the results of the paired-samples T test
as age, gender, marriage, educational status and the du- revealed that, compared with baseline readings, the
ration of PTCA procedure (P value > 0.05) (Table 1). level of anxiety in the experimental group significantly
As Tables 2 and 3 show, before the intervention, the decreased after the intervention (32.06 ± 8.57 vs. 41.16 ±
study groups did not differ significantly regarding anxi- 10.6; P = 0.001; Table 3). However, the level of anxiety in
ety level and hemodynamic parameters (P > 0.05), con- the control group did not decrease significantly at the
firming the similarity of the groups before the study. end of the study (Table 3).

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Forooghy M et al.

Table 2. Hemodynamic Parameters in Both Study Groups Throughout the Study a


Group Time, min P Value b
T1 T2 T3 T4 T5
SBP, mmHg
Control 137.12 ± 17.69 139.94 ± 32.55 138.75 ± 24.28 136.32 ± 23.08 130.56 ± 3.21 0.208
Experimental 138.81 ± 20.54 153.63 ± 32.57 142.38 ± 23.93 139.84 ± 22.34 130.09 ± 21.39 0.001
P value c 0.726 0.098 0.550 0.545 0.925 -
DBP, mmHg
Control 85.22 ± 11.64 83.22 ± 12.01 80.44 ± 10.29 81.19 ± 11.24 79.59 ± 10.15 0.094
Experimental 84.81 ± 10.46 87.44 ± 15.65 85.38 ± 15.92 83.31 ± 12.51 78.56{14.16 0.006
P value c 0.884 0.231 0.147 0.279 0.739 -
HR, Per min
Control 75.34 ± 15.51 79.28 ± 14.40 80.16 ± 14.26 79.31 ± 12.64 74.37 ± 14.03 0.001
Experimental 75.94 ± 12.91 78.28 ± 15.13 79.41 ± 13.31 78.68 ± 12.81 71.91 ± 9.64 0.001
P value c 0.868 0.787 0.829 0.844 0.415 -
SaO2, %
Control 95.03 ± 2.18 93.72 ± 1.27 93.22 ± 2.3 93.19 ± 2.63 94.09 ± 1.91 0.001
Experimental 94.38 ± 2.60 93.34 ± 2.54 91.91 ± 3.08 92.32 ± 3.37 94.19 ± 2.42 0.001
P value c 0.278 0.459 0.058 0.260 0.864 -
RR, Per min
Control 19.22 ± 2.52 - - - 18.66 ± 3.31 -
Experimental 19 ± 2.53 - - - 19.44 ± 10.14 -
P value c 0.732 - - - 0.680 -
a Abbreviations: DBP, Diastolic blood pressure; HR, Hear rate; SBP, systolic blood pressure; RR, Respiration rate; SaO2, Saturation of arterial oxygen.
b Results of the RM ANOVA.
c Results of independent-samples T test.

Table 3. The Levels of Anxiety in Both Study Groups Before and After the Intervention a
Group Time, min
T1 T5 P Value b
Control 41.91 ± 9.88 38.97 ± 12.77 0.101
Experimental 41.16 ± 10.65 32.06 ± 8.57 0.001
P value c 0.771 0.014 -
a Data are presented as Mean ± SD.
b Results of paired-samples T test.
c Results of independent-samples T test.

5. Discussion
The aim of this study was to examine the effect of found that music therapy was not effective in alleviat-
music therapy on patients’ anxiety and hemodynamic ing cardiac surgery-related anxiety (26). Almerud and
parameters during PTCA. Study findings revealed that Petersson noted that music affects the brain, stimulates
music therapy had significant effects on patients’ anxi- the generation of alpha brain waves and the secretion of
ety. However, despite receiving standard nursing care, endorphins, produces relaxation, and relieves fear and
patients in the control group did not experience any anxiety (22). Moreover, it alleviates patients’ pain and
significant change in their anxiety level. Argstatter et al. anxiety through distracting them from the causes of
(30), Weeks et al. (31) and Dogan and Senturan (32) have anxiety (21). Accordingly, it seems that music interven-
also found that music intervention can significantly re- tion in the present study might also alleviated anxiety
duce patients’ anxiety during cardiac catheterization, by distracting patients’ attention from the environmen-
coronary angiography and PTCA. In contrast, Nilsson tal factors that caused anxiety.

Nurs Midwifery Stud. 2015;4(2):e25800 5


Forooghy M et al.

The present study also showed that music interven- Authors’ Contributions
tion did not significantly affect patients’ hemodynamic
Elaheh Mottahedian Tabrizi and Masoumeh Forooghy,
parameters. The insignificant changes of hemodynamic
designed the study. Masoumeh Forooghy collected the
parameters, following music therapy, can be attributed
data. Ebrahim Hajizadeh and Masoumeh Forooghy ana-
to the fact that, during PTCA, hemodynamic parameters
lyzed the data. Masoumeh Forooghy, Elaheh Mottahedian
are monitored and maintained at normal levels to pre-
Tabrizi, Ebrahim Hajizadeh, and Bahram Pishgoo contrib-
vent patients from developing life-threatening complica-
uted to drafting the manuscript.
tions. For instance, if a patient develops bradycardia or
hypertension, atropine and nitroglycerin are adminis-
tered to normalize HR and BP, respectively. Previous stud- Funding/Support
ies reported conflicting findings regarding the effect of Nursing faculty and Behavioral Sciences Research
music therapy on hemodynamic parameters. Argstatter Center, Baqiyatallah University of Medical Sciences,
et al. found no significant HR changes following music Tehran, IR Iran.
therapy (30). Sendelbach et al. have also reported that
music therapy had no significant effect on HR, DBP, and
SBP in patients undergoing cardiac surgery (27). More- References
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